Powers John H, Bacci Elizabeth D, Guerrero M Lourdes, Leidy Nancy Kline, Stringer Sonja, Kim Katherine, Memoli Matthew J, Han Alison, Fairchok Mary P, Chen Wei-Ju, Arnold John C, Danaher Patrick J, Lalani Tahaniyat, Ridoré Michelande, Burgess Timothy H, Millar Eugene V, Hernández Andrés, Rodríguez-Zulueta Patricia, Smolskis Mary C, Ortega-Gallegos Hilda, Pett Sarah, Fischer William, Gillor Daniel, Macias Laura Moreno, DuVal Anna, Rothman Richard, Dugas Andrea, Ruiz-Palacios Guillermo M
Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc., NCI Campus at Frederick, Frederick, MD, USA.
Evidera, Seattle, WA, USA.
Value Health. 2018 Feb;21(2):210-218. doi: 10.1016/j.jval.2017.04.014. Epub 2017 Jun 7.
To assess the reliability, validity, and responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) scores for quantifying the presence and severity of influenza symptoms.
An observational prospective cohort study of adults (≥18 years) with influenza-like illness in the United States, the United Kingdom, Mexico, and South America was conducted. Participants completed the 37-item draft FLU-PRO daily for up to 14 days. Item-level and factor analyses were used to remove items and determine factor structure. Reliability of the final tool was estimated using Cronbach α and intraclass correlation coefficients (2-day reliability). Convergent and known-groups validity and responsiveness were assessed using global assessments of influenza severity and return to usual health.
Of the 536 patients enrolled, 221 influenza-positive subjects comprised the analytical sample. The mean age of the patients was 40.7 years, 60.2% were women, and 59.7% were white. The final 32-item measure has six factors/domains (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic), with a higher order factor representing symptom severity overall (comparative fit index = 0.92; root mean square error of approximation = 0.06). Cronbach α was high (total = 0.92; domain range = 0.71-0.87); test-retest reliability (intraclass correlation coefficient, day 1-day 2) was 0.83 for total scores and 0.57 to 0.79 for domains. Day 1 FLU-PRO domain and total scores were moderately to highly correlated (≥0.30) with Patient Global Rating of Flu Severity (except nose and throat). Consistent with known-groups validity, scores differentiated severity groups on the basis of global rating (total: F = 57.2, P < 0.001; domains: F = 8.9-67.5, P < 0.001). Subjects reporting return to usual health showed significantly greater (P < 0.05) FLU-PRO score improvement by day 7 than did those who did not, suggesting score responsiveness.
Results suggest that FLU-PRO scores are reliable, valid, and responsive to change in influenza-positive adults.
评估流感患者报告结局（FLU-PRO©）评分在量化流感症状的存在及严重程度方面的可靠性、有效性和反应性。
在美国、英国、墨西哥和南美洲对患有流感样疾病的成年人（≥18岁）进行了一项观察性前瞻性队列研究。参与者连续14天每天完成37项的FLU-PRO草案。采用项目层面分析和因子分析来删除项目并确定因子结构。使用Cronbach α系数和组内相关系数（2天可靠性）来估计最终工具的可靠性。通过对流感严重程度的整体评估和恢复至正常健康状态来评估收敛效度、已知组效度和反应性。
在纳入的536例患者中，221例流感阳性受试者构成分析样本。患者的平均年龄为40.7岁，60.2%为女性，59.7%为白人。最终的32项测量指标有六个因子/领域（鼻子、喉咙、眼睛、胸部/呼吸道、胃肠道和身体/全身），一个高阶因子代表总体症状严重程度（比较拟合指数=0.92；近似均方根误差=0.06）。Cronbach α系数较高（总体=0.92；领域范围=0.71-0.87）；重测信度（组内相关系数，第1天至第2天）总分是0.83，各领域为0.57至0.79。第1天的FLU-PRO领域和总分与患者对流感严重程度的总体评分呈中度至高度相关（≥0.30）（鼻子和喉咙领域除外）。与已知组效度一致，评分根据总体评分区分了严重程度组（总体：F=57.2，P<0.001；领域：F=8.9-67.5，P<0.001）。报告恢复至正常健康状态的受试者在第7天时FLU-PRO评分的改善显著大于未恢复者（P<0.05），表明评分具有反应性。
结果表明，FLU-PRO评分在流感阳性成年人中具有可靠性、有效性且对变化有反应性。
